MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ASPIRA PERITONEAL DRAINAGE KIT 1L; PERITONEAL DIALYSIS SYSTEM AND ACCESSORIES

Model Number	N/A
Health Effect - Clinical Code	Dyspnea (1816)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of rebt2301 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per ms and s, the hospice nurse called to report drainage issues with a patient's aspira catheter.After placement, he drained ~1,000 cc.During the last two drainage sessions, he drained ~ 600 cc each time.Today, he only drained ~ 10 cc.He experiences shortness of breath even when he has been able to drain, but his shortness of breath is worse since he isn't getting much fluid out.They tried 2 drainage kits, but the bulb did not expand after squeezing it.

• Brand Name: ASPIRA PERITONEAL DRAINAGE KIT 1L
• Common Device Name: PERITONEAL DIALYSIS SYSTEM AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6880290
• Report Number: 3006260740-2017-01654
• Device Sequence Number: 1364594
• Product Code: PNG
• UDI-Device Identifier: 10801741091121
• UDI-Public: (01)10801741091121
• Combination Product (Y/N): N
• PMA/510(K) Number: K110396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4992207
• Device Lot Number: REBT2301
• Was Device Available for Evaluation?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1